MAUDE Adverse Event Report: PENUMBRA, INC. SWIFTSET COIL; HCG, KRD

Catalog Number	400SWCCL202
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acomm) using a swiftset coil (swiftset), a swift coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician advanced the swiftset into the target vessel and attempted to detach the coil using the handle; however, the swiftset did not detach.The physician retracted the swiftset for removal.The embolization coil then detached within the microcatheter.The microcatheter containing the detached embolization coil was removed.The procedure was completed using a new swiftset, the same handle, and a new non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned swiftset coil (swiftset) confirmed that the embolization coil was detached.The pusher assembly was not returned for evaluation; therefore, the root cause of the reported detachment issue could not be determined.Evaluation also revealed offset coil winds along the embolization coil.This damage is incidental to the complaint, and the root cause could not be determined.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the follow-up #01 mfr report and is being included on this follow-up #02: 1.Section h.Box 2.If follow-up, what type?.

• Brand Name: SWIFTSET COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23729409
• Report Number: 3005168196-2025-00389
• Device Sequence Number: 9667616
• Product Code: HCG
• UDI-Device Identifier: 00810169721926
• UDI-Public: 00810169721926
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 400SWCCL202
• Device Lot Number: C00018839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/16/2026; Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/28/2026; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female